Apparatus, kit and related methods for administering substances

ABSTRACT

An apparatus, kit and related methods for orally administering a substance such as a medicine. The apparatus includes a straw with a barrier device movable in a direction of sucking. The apparatus is configured so that movement of the barrier device in a direction against the direction of sucking is limited.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of International Patent ApplicationNo. PCT/EP2004/001395, filed Feb. 13, 2004, designating the UnitedStates of America, and published in German as WO 2004/075876 A1, theentire disclosure of which is incorporated herein by reference. Priorityis claimed based on German Patent Application No. 103 08 175.5, filedFeb. 25, 2003.

FIELD OF THE INVENTION

The present invention relates to an apparatus and a kit for orallyadministering a substance as well as related methods of administration.In particular, the invention relates to an apparatus for the oraladministration of active ingredients, vitamins and/or nutrientscomprising a drinking straw with a barrier device which is impermeableto an active ingredient, vitamin and/or nutrient formulation, but ispermeable to air and a conveying liquid within the drinking straw and isslidable substantially only in the direction of sucking, the slidingsurfaces of which barrier device are configured such that motion of thebarrier device contrary to the direction of sucking is at least mademore difficult, and to a kit made up of the apparatus and a conveyingliquid.

BACKGROUND OF THE INVENTION

It is known to administer active ingredients, vitamins and/or nutrientswith the assistance of a drinking straw which contains an activeingredient, vitamin and/or nutrient formulation which is conveyable by aliquid. Patients who have difficulty in or an aversion to takingcapsules or tablets are provided in this manner with a further apparatusfor active ingredients, vitamins or nutrients.

The drinking straws known from the prior art for the oral administrationof active ingredients, vitamins and/or nutrients do not, however, offerthe option of reliably checking complete consumption of the activeingredient formulation. Due to the large number of medicines to beadministered, it is not possible for care staff in hospitals or carehomes to provide continuous supervision of the taking of medicines. Itis therefore desirable to have a simple way of checking complete intakeof a medicine from the drinking straw.

SUMMARY OF THE INVENTION

One object of certain embodiments of present invention is to provide anapparatus and a kit, which permits simple, reliable checking of completeuptake of a medicinal substance.

This object is achieved by an apparatus for the oral administration ofsubstances such as active ingredients, vitamins and/or nutrientscomprising a drinking straw, which has two orifices and a barrier devicewhich is at least substantially impermeable to a substance beingadministered but is permeable to air and a conveying liquid and isslidable in the direction of sucking. In the apparatus, at least part ofthe sliding surface of the barrier device is configured such that motionof the barrier device contrary to the direction of sucking is at leastmade more difficult.

In the apparatus, complete withdrawal or intake of the substance beingadministered, in particular, the active ingredient-, vitamin- and/ornutrient-containing formulation is indicated by a slidable barrierdevice undergoing a change in its position within the drinking straw inaccordance with the intake. The apparatus consequently makes it possibleto ascertain from the position of the barrier device the intake,preferably the complete intake, of a medicine. In the event of completeintake of the substance, the barrier device is located at the end of thedrinking straw which comprises the orifice facing towards the mouth.

The barrier device is slidable in the direction of sucking and largelynot moveable in the contrary direction. The barrier device is suitablefor permitting the passage of a conveying liquid and air, but not theactive ingredient, vitamin and/or nutrient formulation in the drinkingstraw. The barrier device is preferably mobile only in the direction ofsucking.

The immobilization of the barrier device is ensured by configuring atleast part of the sliding surface of the barrier device such thatmovement contrary to the direction of sucking is at least made moredifficult and is preferably completely prevented. In this manner it ispossible to indicate the particular withdrawal of the substance by thechange in position of the barrier device. The change in position iseffected by sucking conveying liquid up through the drinking straw,whereby the barrier device according to the invention and the substanceare conveyed.

The configuration of the sliding surface for limiting the directionalmovement of the barrier device is preferably provided by a regulararrangement with identically shaped movement-limiting structures, suchas for example scales, sawteeth or pyrimidal structures.

In a preferred embodiment of the invention, the sliding surfaces of thebarrier device substantially reproduce the surface of sharkskin. Theperson skilled in the art will understand that sharkskin isdistinguished by a plurality of pyramidal structures which arepreferably flattened or oriented contrary to the desired direction ofmotion (direction of sucking), whereby particularly good flowcharacteristics are achieved. In the contrary direction, however,particularly strong resistance to flow or frictional resistance isprovided, such that a barrier device configured in this manner issubstantially moveable only in the direction of sucking. This surfacestructure is preferably present over the entire circumference of thebarrier device.

In a further preferred embodiment of the invention, the sliding surfacesof the barrier device comprise at least in part a scale structure,preferably similar to fish skin or to the sliding surfaces ofcross-country skis. The scales here particularly preferably comprise astraight edge which faces towards the direction of flow and runssubstantially perpendicularly to the direction of sucking and anopposing edge which is substantially semicircular in shape. These scalesmay be arranged both diagonally offset relative to one another and onebehind the other. In an especially preferred development of theinvention, however, the scales are arranged on the sliding surfaces insuch a manner that the substantially semicircular edge of a first scaleis arranged over the straight edge, which is perpendicular to thedirection of sucking, of a second scale. This structure is preferablypresent over the entire circumference of the barrier device. Theresultant rows of scales are arranged substantially perpendicular to thedirection of sucking.

Providing such a structure on the surface of the barrier device createsa checkable apparatus because, without any appreciable reduction in thediameter of the barrier device, sliding of the barrier device is allowedin the direction of sucking while any sliding back on completion ofsucking is virtually eliminated.

In a further particularly preferred embodiment of the invention, thesliding surfaces of the barrier device comprise at least in part aregular arrangement of sawteeth, the sloping face of which is directedsubstantially contrary to the direction of sucking. In the contrarydirection, in contrast, the sawteeth preferably do not have a slopingface, but instead a substantially right-angled transition from thesliding surface of the barrier device to the individual sawteeth,especially when at least these sawteeth are made of a relatively rigidmaterial. If the sawteeth are made of a relatively resilient material,such that, due to the corresponding diameter of the barrier device, theyassume the above-described configuration on introduction into thedrinking straw, the sawteeth need not exhibit a different sloping face.

In a further preferred embodiment of the invention, this configurationof the sliding surfaces extends over the entire circumference of thebarrier device. A person skilled in the art will understand that, in thedevelopment with sawteeth extending over the entire circumference of thebarrier device, rows, preferably arranged over one another and slopingcontrary to the direction of sucking, are provided and are arrangedsubstantially perpendicularly to the direction of sucking. Veryparticularly preferably, the above-stated configurations simply extendover the entire circumference, but only over part of the slidingsurfaces of the barrier device. In an especially preferred developmentof the invention, this surface configuration is embodied in segments ofthe sliding surface which are preferably distributed uniformly over thecircumference of the sliding surfaces.

The material of the sliding surface is preferably the same as that ofthe remainder of the barrier device. The material preferably exhibitssufficient resilience in order to allow the surface structure to lieflat on sucking while simultaneously allowing the surface structure tospring back up. Plastics, whether synthetic or natural, which may alsobe foamed, may be considered for this purpose. In this manner, a barrierdevice is created which is particularly light in weight. Such apparatusaccording to the invention may also be used by particularly weakpatients without requiring a high level of exertion.

The barrier devices with the surface structures according to theinvention may be produced by extrusion and/or injection moulding or bysurface machining, such as embossing.

The interior of the barrier device may preferably also consist of filtermaterial, particularly preferably of nonwoven material or compressedfibrous material. The barrier device is accordingly comparable to acigarette filter. A surface structure according to the invention may,for example, be produced by jacketing such a barrier device with aplastics film, preferably a tubular film, which already comprises anappropriately configured surface structure. In one particularlypreferred development of the invention, such a barrier device is joinedwith a structured film according to the invention by means of anadhesive which is safe for use in contact with foodstuffs. Thislamination may proceed continuously or discontinuously on thesemifinished product or on the singulated product. The surface filmpreferably comprises the embossing according to the invention.

The barrier device preferably comprises continuous channels such thatthe conveying liquid can not only flow around but also through thebarrier device. This configuration of the barrier device may be selectedin accordance with the weight of the barrier device. Care must here betaken to ensure that the orifice of the channels does not permit aparticulate formulation of the substance or another form of thesubstance to pass through.

The dimensions of the barrier device are adapted to the dimension of thedrinking straw, wherein, in the case of a round drinking straw, thediameter of the barrier device is adapted, taking account of the surfaceconfiguration of the barrier device, to the internal diameter of thedrinking straw. The barrier device is otherwise preferably cylindrical,particularly preferably a plug.

According to one embodiment of the invention, the barrier device ismobile between a limit stop at the orifice which is not the mouthorifice, and the sucking orifice (mouth orifice). In a particularlypreferred embodiment of the invention, another limit stop is arranged inthe immediate vicinity of the mouth orifice. The drinking straw isnarrowed by the limit stops, wherein the narrowed portions are designedsuch that the barrier device is retained thereby, but the formulationparticles which may be insoluble in the conveying liquid, are not. Inthis manner, an apparatus is created in which intake of the formulationmay be checked and uptake of the barrier device by patients may reliablybe prevented.

The drinking straw may be rigid or flexible, straight or angled and/orpreferably reversibly bendable. The drinking straw preferably consistsof a synthetic material.

In a preferred embodiment of the invention, the drinking straw comprisestwo substantially straight legs joined together via a bend and/orbending means. In a particularly preferred development of the invention,the bending means are preferably reversible. In this design of thedrinking straw, the barrier device and the formulation are arranged inthe leg comprising the mouth orifice between the bending means and themouth orifice. In this manner, a device is created which is particularlyeasy to store and simultaneously facilitates intake by recumbentpatients.

The drinking straw preferably comprises a transparent outer wall atleast in the zone of the orifice facing towards the patient. In aparticularly preferred development of the invention, the transparentouter wall here extends over part of the circumference of the drinkingstraw. In this manner, an apparatus is created which makes it possibleto check the position of the barrier device and thus the extent ofintake of the formulation.

The internal diameter of the drinking straw should preferably be atleast 3 mm, whereby a sufficient quantity of conveying liquid can besucked through the straw in order to convey the barrier device and theformulation. An internal diameter of 3-20 mm is preferred, with 4-15 mmbeing particularly preferred and 5-10 mm very particularly preferred.

The drinking straw orifice, in which the active ingredient, vitaminand/or nutrient formulation and the barrier device may be conveyedlargely unimpeded, preferably takes the form of a mouthpiece,particularly preferably ribbed, while the other orifice may preferablytake the form of a connecting piece to a reservoir of the conveyingliquid. The drinking straw is preferably labelled to indicate the mouthpart and/or to indicate the direction of sucking for the conveyingliquid. Such marking simplifies handling.

In a further preferred development of the invention, at least one of theorifices of the drinking straw comprises a removable closure. In aparticularly preferred development of the invention, the closure is acap or a preferably peelable seal made from a membrane or film.

The active ingredient, vitamin and/or nutrient formulation is preferablysolid or pasty at the storage temperature of the system according to theinvention, preferably at 25° C. A multiparticulate active ingredient,vitamin and/or nutrient formulation is preferred, wherein theformulation particularly preferably assumes the form of particles,preferably solid particles.

The active ingredients, vitamins and/or nutrients alone or the overallactive ingredient, vitamin and/or nutrient formulations may be solubleor insoluble in the conveying liquid.

If the active ingredients, vitamins and/or nutrients or the overallformulations are soluble in the conveying liquid, they are dissolved bythe sucked up conveying liquid and administered in dissolved form. If,on the other hand, the active ingredients, vitamins and/or nutrients orthe overall formulations are insoluble in the conveying liquid, they aremerely conveyed onwards by the sucked up conveying liquid.Multiparticulate formulations are preferably used. The particles shouldhere exhibit dimensions such that they may readily be conveyed out ofthe drinking straw by sucking up the conveying liquid. Adhesion of theparticles to one another or to the walls of the drinking straw should beprevented, which may optionally be achieved by suitable surfacetreatment of the particles. The particles preferably have a diameter inthe range from 100-1500 μm, preferably 150-800 μm. The formulation mayalso assume tablet form.

Any orally administrable substances may be used as the activeingredients, preferably therapeutic active ingredients, vitamins ornutrients, provided that a suitable formulation is possible for thesystem according to one embodiment of the invention. The apparatuspreferably contains a precisely determined dose of these substances,which are approved or acceptable for administration to humans andanimals, preferably to humans. Therapeutic active ingredients are nottaken to include nicotines, such as laevo-nicotine, dextro-nicotine, theracemic mixtures and/or pharmaceutical salts thereof.

The active ingredient, vitamin and/or nutrient formulation is arranged,according to one embodiment of the invention, within the drinking strawin the direction of sucking of the conveying liquid between the barrierdevice and the mouth orifice of the drinking straw.

In one embodiment of the invention, the active ingredient, vitaminand/or nutrient formulation may also be immobilized in the drinkingstraw and be moveable only by contact with the conveying liquid. To thisend, the formulation may be bound to the internal wall of the drinkingstraw, to the barrier device and/or an optionally present carrier madefrom a physiologically acceptable material which is soluble in theconveying liquid and/or itself bound adhesively and/or with theassistance of a physiologically acceptable binding material which issoluble in the conveying liquid.

The formulation may preferably be immobilized with the assistance ofsugars and/or sugar-like compounds, preferably sucrose, glucose,fructose, mannitol, sorbitol, flucose, maltose, lactose, galactose,trehalose and/or sugar alcohols, of cyclic sugars, preferablycyclodextrins, of proteins, preferably gelatines, gelatine derivatives,gelatine hydroxylates, dextrins, proteins from soya, wheat and/orpsyllium seeds, of gums and/or gum-like materials, preferably agar,acacia, guar, xanthan, of starch, preferably starch consisting ofamylose with up to 6000 glucose units and amylopectin with 10-60 glucoseunits, of modified starch, preferably starch with esterified hydroxygroups, hydroxyethyl starch, hydroxypropyl starch and/or distarchphosphates, of pectins, of dextrans, of cellulose derivatives,preferably methylcellulose, ethylcellulose, hydroxymethylcellulose,hydroxyethylcellulose and/or carboxymethylcellulose, optionally as analkali metal salt, of alginates, of carrageenans, of amino acids,preferably with 2-12 carbon atoms, particularly preferably glycine,L-alanine, L-aspartic acid, L-glutamic acid, L-hydroxyproline,L-leucine, L-isoleucine and/or L-phenylalanine, of synthetic polymers,preferably polyvinylpyrrolidone, of inorganic salts, preferably sodiumphosphate, sodium chloride and/or aluminium silicate, or mixtures.

A carrier used for immobilization preferably consists of a cottonwool-like plug of sugar, preferably sucrose, glucose, fructose,mannitol, sorbitol, flucose, lactose and/or maltose, of a solublecellulose material, preferably methylcellulose, ethylcellulose,hydroxymethylcellulose, hydroxyethylcellulose and/or an alkali metalsalt of carboxymethylcellulose, or mixtures thereof.

If the drinking straw comprises a bend or bending means, the barrierdevice is arranged and is mobile between the bending zone and the mouthorifice of the drinking straw and, before withdrawal of the formulation,is positioned between the bending zone of the drinking straw and themouth orifice thereof.

In a preferred embodiment of the invention, an additional closing deviceis arranged within the drinking straw. The closing device preferablyserves to prevent a moveable formulation from falling out of thedrinking straw before use of the apparatus according to the invention.

The closing device according to the invention is arranged, in thedirection of sucking of the conveying liquid, between the activeingredient, vitamin and/or nutrient formulation and the mouth orifice ofthe drinking straw and preferably consists of a physiologicallyacceptable material which is soluble in the conveying liquid.

Such a closing device is preferably configured from the same materials,as the above-described immobilization carrier.

The closing device may optionally also serve as a carrier forimmobilizing active ingredients, vitamins and/or nutrients.

Alternatively or additionally, the orifice of the drinking straw whichfaces the active ingredient, vitamin and/or nutrient formulation, may beprovided with a closure. The closure is preferably a cap or a plug,which is preferably removed immediately before oral administration.

In a preferred embodiment of the invention, the closure is a closuremade from an at least partially removable and/or destructible filmattached to the drinking straw orifice, which closure closes at leastthe drinking straw orifice facing the formulation and is impermeable tothe active ingredient, vitamin and/or nutrient formulation beforeadministration.

The film may be compact, porous or mesh-like. The film is preferablypeelable, separable, severable, pierceable, is separable and/orseverable, particularly preferably only partially, by suction forceand/or is soluble in saliva. In order to facilitate separation and/orsevering of the film closure, the film may comprise weakening lines,preferably predetermined separating or breaking points, which preferablyrun radially outwards from the middle of the closure and divide theclosure into preferably identically sized segments.

This closing device is preferably configured from materials, which arethe same as the above carrier.

In order to protect a film-type closing device, the drinking straworifice may additionally be provided with a cap.

The second drinking straw orifice may optionally also be provided withthe above-described film and/or cap.

The present invention also provides a kit made up of the apparatusaccording to the invention and a physiologically acceptable conveyingliquid which optionally also contains active ingredients, nutrientsand/or vitamins. An aqueous liquid is preferably used as the conveyingliquid, wherein water, lemonade, fruit juice without fruit pulp, tea orcoffee are particularly preferred and should not contain any troublesomesolids, such as pieces of fruit pulp.

The invention is explained in greater detail below with reference to twoFigures. These Figures are, however, merely exemplary representations ofan apparatus produced in accordance with one embodiment of the inventionand do not in any way restrict the general concept of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a partial view of an apparatus according to the invention,

FIG. 2 shows a magnified partial view of an apparatus according to theinvention.

DETAILED DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a partial view of a drinking straw 1, which consists ofstraight legs 8, 12 connected to one another via the accordion-likebending means 15. The drinking straw 1 has the orifices 6, 9, whereinorifice 6 is intended to be placed in the patient's mouth and theorifice 9 is immersed in the conveying liquid (not shown). A mobilebarrier device 3 is arranged in the drinking straw 1 above the bendingmeans 15 of the drinking straw 1. A multiparticulate active ingredientformulation 7 is arranged downstream in the direction of sucking 5 fromthe barrier device 3. A membrane-like closing device 4 made from aphysiologically acceptable material which is soluble in the conveyingliquid is arranged in the drinking straw downstream in the direction ofsucking 5 from the formulation 7. The barrier device 3 can move in thedrinking straw 1 only in the direction of sucking 5 and between thebending means 15 and the limit stop 10. After dissolution of at leastpart of the closing device 4, the mobile barrier device is moved onsucking the conveying liquid up through the drinking straw 1 togetherwith the formulation 7 towards the orifice 6. The formulation 7 may beconveyed substantially unimpeded with the at least partially dissolvedclosing device 4 to the orifice 6. Due to the surface configuration ofits sliding surface (not shown), the barrier device 3 is held in thisposition and prevented from moving back. The barrier device 3 isadditionally visible from the outside through the viewing window 14 whenthe formulation has been withdrawn. The person skilled in the art willunderstand that complete intake, or administration of the formulationmay be ascertained when the barrier device 3 rests against the upperlimit stop 10.

FIG. 2 shows a magnified representation of a part of the leg 8 with theorifice 6 after the formulation has been sucked up. The orifice 6 isclosed by a removable cap 13. Beneath the limit stop 10, which extendsaround the entire internal circumference of the leg 8, the leg 8comprises a transparent viewing window 14, which extends over part ofthe circumference and part of the length of the leg 8 and permits visualverification of the withdrawal of the formulation. The barrier device 3which is mobile within the drinking straw 1 comprises on its slidingsurface 2 two opposing rows of sawteeth, which slope exclusivelycontrary to the direction of sucking 5.

The foregoing description and examples have been set forth merely toillustrate the invention and are not intended to be limiting. Sincemodifications of the described embodiments incorporating the spirit andsubstance of the invention may occur to persons skilled in the art, theinvention should be construed broadly to include all variations fallingwithin the scope of the appended claims and equivalents thereof.

LIST OF REFERENCE NUMERALS

-   1 Drinking straw-   2 Sliding surface-   3 Barrier device-   4 Closing device-   5 Direction of sucking-   6 Orifice of the drinking straw-   7 Formulation-   8 Leg of the drinking straw-   9 Orifice of the drinking straw-   10 Limit stop-   12 Leg of the drinking straw-   13 Closure-   14 Viewing window-   15 Bending means

1. An apparatus for use in orally administering a substance, saidapparatus comprising: a drinking straw having two orifices and a barrierdevice, said barrier device being substantially impermeable to thesubstance to be administered, and being permeable to air and a conveyingliquid and being movable in a direction of sucking, wherein at leastpart of an outer surface of the barrier device is configured such thatmovement of the barrier device contrary to the direction of sucking issubstantially prevented.
 2. An apparatus according to claim 1, whereinthe barrier device is moveable only in the direction of sucking.
 3. Anapparatus according to claim 1, wherein at least part of the outersurface of the barrier device has a sawtooth arrangement orientedcounter to the direction of sucking.
 4. An apparatus according to claim1, wherein at least part of the outer surface of the barrier device hasa sharkskin configuration.
 5. An apparatus according to claim 1, whereinat least part of the outer surface of the barrier device has a scaleconfiguration.
 6. An apparatus according to claim 1, wherein the entireouter surface of the barrier device is configured such that movement ofthe barrier device contrary to the direction of sucking is substantiallyprevented.
 7. An apparatus according to claim 1, wherein thecircumference of the outer surface of the barrier device is configuredsuch that movement of the barrier device contrary to the direction ofsucking is substantially prevented.
 8. An apparatus according to claim1, wherein the barrier device is moveable in the drinking strawsubstantially up to one of the two orifices of the drinking straw.
 9. Anapparatus according to claim 1, wherein movement of the barrier deviceis limited to part of a length of the drinking straw.
 10. An apparatusaccording to claim 9, wherein the drinking straw comprises at least onelimit stop to limit the movement of the barrier device.
 11. An apparatusaccording to claim 1, wherein the barrier device has a substantiallycylindrical shape.
 12. An apparatus according to claim 11, wherein thebarrier device is a plug.
 13. An apparatus according to claim 1, whereinthe substance to be administered is arranged between the barrier deviceand one of the two orifices of the drinking straw.
 14. An apparatusaccording to claim 1, wherein the substance to be administered is asolid.
 15. An apparatus according to claim 1, wherein the substance tobe administered is insoluble in the conveying liquid.
 16. An apparatusaccording to claim 1, wherein the substance to be administered ismultiparticulate.
 17. An apparatus according to claim 1, wherein thesubstance to be administered is tabletted.
 18. An apparatus according toclaim 1, wherein the substance to be administered is at least partiallysoluble in the conveying liquid.
 19. A kit for administering asubstance, said kit comprising: an apparatus according to claim 1 and aphysiologically acceptable conveying liquid.
 20. The kit of claim 19,further comprising a substance to be administered.
 21. The kit of claim19, wherein said conveying liquid is an aqueous liquid.
 22. A method ofadministering a substance comprising: providing a drinking straw havingtwo orifices and a barrier device, said barrier device beingsubstantially impermeable to the substance to be administered, and beingpermeable to air and a conveying liquid and being movable in a directionof sucking, wherein at least part of an outer surface of the barrierdevice is configured such that movement of the barrier device contraryto the direction of sucking is substantially prevented; providing asubstance to be administered and a conveying liquid and administeringsaid substance to be administered.